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510(k) Data Aggregation
K Number
K160092Device Name
Digital Electrocardiograph
Manufacturer
SHENZHEN BIOCARE BIO-MEDICAL EQUIPMENT CO., LTD.
Date Cleared
2016-02-12
(28 days)
Product Code
DPS
Regulation Number
870.2340Why did this record match?
Applicant Name (Manufacturer) :
SHENZHEN BIOCARE BIO-MEDICAL EQUIPMENT CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of electrocardiograph is to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart disease. The proposed device has analysis feature, however the ECC with measurements and interpretive statements is offered to clinician on an advisory basis only.
Device Description
The proposed digital electrocardiograph, iE 101 and iE 300, are designed based on the cleared digital electrocardiographs K141946 (iE 3). The proposed device has same intended use, functional modules design, working modes, analysis function and accessories. the proposed devices are different than the predicate device in that they has new printing channel for iE 101); new layout of user-machine interface; three different physical specification, such as screen size, device dimension, device weight; three different specification, such as battery capacity, noise level and CMRR; and a modified software which is modified to applicable to the proposed devices.
The proposed electrocardiographs, iE 101 and iE 300, follow the same design principle, main components, accessories and software; they acquire ECG electrical signals from patient body surface by ECG electrodes. After been amplified, filtered and transferred, the ECG signal waveforms are displayed on the LCD and recorded on the paper through thermal printer.
They consist of four modules, which are power supply module, signal collection module, amplification module, and control module.
They can acquire ECG signal via twelve leads simultaneously, display or print waveform of ECG signal via one channel (iE 101) or three channel (iE 300).
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K Number
K152384Device Name
Digital Electrocardiograph
Manufacturer
SHENZHEN BIOCARE BIO-MEDICAL EQUIPMENT CO., LTD.
Date Cleared
2015-12-18
(116 days)
Product Code
DPS
Regulation Number
870.2340Why did this record match?
Applicant Name (Manufacturer) :
SHENZHEN BIOCARE BIO-MEDICAL EQUIPMENT CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Digital Electrocardiograph is intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and disease. Digital Electrocardiograph shall be used in healthcare facilities by doctors and/or trained healthcare professionals.
Device Description
Digital Electrocardiograph, ECG-2000, is intended to acquire ECG signals from adult patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and diagnose heart disease.
It consists of the acquisition box, optional accessories, installation CD, and USB dongle. The acquisition box is connected with ECG electrodes, and intends to acquire ECG signals from patient. The acquired ECG signal is filtered and amplified, then transferred to the working station. The acquisition box is powered by the working station via a USB line. The working station is a Personal Computer installed with ECG-2000 Software, it intends to receive the processed ECG signal from the acquisition box, and further display and record the signals. Optional accessories include lead wires, limb electrodes and chest electrodes, and general-purpose printer (with USB interface, support PCL language, such as HP1010, P2035, and P2055d series). The CD contains Digital Electrocardiograph installer and dongle installation program module.
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K Number
K141946Device Name
DIGITAL ELECTROCARDIOGRAPH
Manufacturer
SHENZHEN BIOCARE BIO-MEDICAL EQUIPMENT CO., LTD.
Date Cleared
2015-02-13
(211 days)
Product Code
DPS
Regulation Number
870.2340Why did this record match?
Applicant Name (Manufacturer) :
SHENZHEN BIOCARE BIO-MEDICAL EQUIPMENT CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of electrocardiograph is to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart disease. However the ECG with measurements and interpretive statements is offered to clinician on an advisory basis only.
Device Description
Digital Electrocardiograph, iE 3/ iE 6/ iE 12/ iE 12A/ iE 15/ ECG-1210/ ECG-3010/ ECG-6010, are intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart disease. However the ECG with measurements and interpretive statements is offered to clinician on an advisory basis only.
All the proposed models, iE 3/ iE 6/ iE 12/ iE 12A/ iE 15/ ECG1210/ ECG3010/ ECG6010, follow the same design principle, main components, accessories and software; they acquire ECG electrical signals from patient body surface by ECG electrodes. After been amplified, filtered and transferred, the ECG signal waveforms are displayed on the LCD and recorded on the paper through thermal printer.
They consist of four modules, which are power supply module, signal collection module, amplification module, and control module.
They can acquire ECG signal via twelve leads simultaneously, display or print waveform of ECG signal via three channel, six channel, twelve channel or fifteen channel.
The CardioPro analysis program is the analysis program used in this proposed device.
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K Number
K133985Device Name
DIGITAL ELECTROCARDIOGRAPH
Manufacturer
SHENZHEN BIOCARE BIO-MEDICAL EQUIPMENT CO., LTD.
Date Cleared
2015-01-22
(392 days)
Product Code
DPS
Regulation Number
870.2340Why did this record match?
Applicant Name (Manufacturer) :
SHENZHEN BIOCARE BIO-MEDICAL EQUIPMENT CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Digital Electrocardiograph is intended to acquire ECG signals from adult patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and diagnose heart disease. Digital Electrocardiograph shall be used in healthcare facilities by doctors and/or trained healthcare professionals.
Device Description
Digital Electrocardiograph, ECG-2000, is intended to acquire ECG signals from adult patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and diagnose heart disease.
It consists of the acquisition box, optional accessories, installation CD, and USB dongle. The acquisition box is connected with ECG electrodes, and intends to acquire ECG signals from patient. The acquired ECG signal is filtered and amplified, then transferred to the working station. The acquisition box is powered by the working station via a USB line. The working station is a Personal Computer installed with ECG-2000 Software, it intends to receive the processed ECG signal from the acquisition box, and further display and record the signals. Optional accessories include lead wires, limb electrodes and chest electrodes, and general-purpose printer (with USB interface, support PCL language, such as HP1010, P2035, and P2055d series). The CD contains Digital Electrocardiograph installer and dongle installation program module.
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K Number
K132758Device Name
DIGITAL ELECTROCARDIOGRAPH
Manufacturer
SHENZHEN BIOCARE BIO-MEDICAL EQUIPMENT CO., LTD.
Date Cleared
2014-01-30
(148 days)
Product Code
DPS
Regulation Number
870.2340Why did this record match?
Applicant Name (Manufacturer) :
SHENZHEN BIOCARE BIO-MEDICAL EQUIPMENT CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Digital Electrocardiographs are intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and diagnose heart disease. Digital Electrocardiographs shall be used in healthcare facilities by doctors and/or trained healthcare professionals.
Device Description
Digital Electrocardiographs, iE 3, iE 6, are intended to acquire, display and record ECG signals from adult and pediatric patients through body surface by ECG electrodes. ECG data result and patient information could be stored in the memory of the device. The obtained ECG records can help users to analyze and diagnose heart disease.
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